[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Proposed Rules]
[Page 10627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-04180]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / 
Proposed Rules  

[[Page 10627]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. APHIS-2014-0095]
RIN 0579-AE08


Agricultural Bioterrorism Protection Act of 2002; Biennial Review 
and Republication of the Select Agent and Toxin List

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Advance notice of proposed rulemaking and request for comments.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Agricultural Bioterrorism Protection 
Act of 2002, we are soliciting public comment regarding the list of 
select agents and toxins that have the potential to pose a severe 
threat to animal or plant health, or to animal or plant products. The 
Act requires the biennial review and republication of the list of 
select agents and toxins and the revision of the list as necessary. 
Accordingly, we are soliciting public comment on the current list of 
select agents and toxins in our regulations and suggestions regarding 
any addition or reduction of the animal or plant pathogens currently on 
the list of select agents.

DATES: We will consider all comments that we receive on or before April 
28, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0095, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-
0095 or in our reading room, which is located in Room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Charles L. Divan, Unit Director, 
Agricultural Select Agent Services, APHIS, 4700 River Road Unit 2, 
Riverdale, MD 20737-1231; (301) 851-3300.

SUPPLEMENTARY INFORMATION: The Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 provides for the regulation of 
certain biological agents and toxins that have the potential to pose a 
severe threat to human, animal, and plant health, or to animal and 
plant products. The Animal and Plant Health Inspection Service (APHIS) 
has the primary responsibility for implementing the provisions of the 
Act within the U.S. Department of Agriculture (USDA). Veterinary 
Services (VS) select agents and toxins, listed in 9 CFR 121.3, are 
those that have been determined to have the potential to pose a severe 
threat to animal health or animal products. Plant Protection and 
Quarantine (PPQ) select agents and toxins, listed in 7 CFR 331.3, are 
those that have been determined to have the potential to pose a severe 
threat to plant health or plant products. Overlap select agents and 
toxins, listed in 9 CFR 121.4, are those that have been determined to 
pose a severe threat to public health and safety, to animal health, or 
to animal products. Overlap select agents are subject to regulation by 
both APHIS and the Centers for Disease Control and Prevention, which 
has the primary responsibility for implementing the provisions of the 
Act for the Department of Health and Human Services.
    Title II, Subtitle B of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (which is cited as the 
``Agricultural Bioterrorism Protection Act of 2002'' and referred to 
below as the Act), section 212(a), provides, in part, that the 
Secretary of Agriculture (the Secretary) must establish by regulation a 
list of each biological agent and each toxin that the Secretary 
determines has the potential to pose a severe threat to animal or plant 
health, or to animal or plant products.
    In determining whether to include an agent or toxin in the list, 
the Act requires that the following criteria be considered:
     The effect of exposure to the agent or toxin on animal or 
plant health, and on the production and marketability of animal or 
plant products;
     The pathogenicity of the agent or the toxin and the 
methods by which the agent or toxin is transferred to animals or 
plants;
     The availability and effectiveness of pharmacotherapies 
and prophylaxis to treat and prevent any illness caused by the agent or 
toxin; and
     Any other criteria that the Secretary considers 
appropriate to protect animal or plant health, or animal or plant 
products.
    Paragraph (a)(2) of section 212 of the Act requires the Secretary 
to review and republish the list of select agents and toxins every 2 
years and to revise the list as necessary. To fulfill this statutory 
mandate, PPQ and VS each convene separate interagency working groups in 
order to review the lists of PPQ and VS select agents and toxins, as 
well as any overlap select agents and toxins, and develop 
recommendations regarding possible changes to the list using the four 
criteria for listing found in the Act. In this document, we are asking 
for comments on the current list \1\ of select agents and toxins and on 
any other significant pathogens so as to inform the working groups as 
they begin the biennial review process.
---------------------------------------------------------------------------

    \1\ You may view the lists of select agents and toxins on the 
Internet at http://www.selectagents.gov/SelectAgentsandToxinsList.html.
---------------------------------------------------------------------------

    This action has been determined to be not significant for the 
purposes of Executive Order 12866 and, therefore, has not been reviewed 
by the Office of Management and Budget.

    Authority:  7 U.S.C. 8401; 7 CFR 2.22, 2.80, 371.3, and 371.4.

    Done in Washington, DC, this 23rd day of February 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-04180 Filed 2-26-15; 8:45 am]
BILLING CODE 3410-34-P